CoChat
Sign Up
Cited by 16Antibiotic Use and ResistancePharmaceutical Economics and PolicyPharmaceutical industry and healthcare

The impact of stringent prescription-only antimicrobial sale regulation (Schedule H1) in India: an interrupted time series analysis, 2008–18

Open access
Farooqui, Habib Hasan, Selvaraj, Sakthivel, Mehta, Aashna, Mathur, Manu Raj·2020·JAC-Antimicrobial Resistance
DOI 10.1093/jacamr/dlaa076PMC PMC8210317
Open this paper in CoChat — free accountOpen PDF

Abstract

Abstract Objectives To assess the impact of Schedule H1 regulation notified and implemented in 2014 under the amended rules of the Drugs and Cosmetics Act (DCA), 1940 on the sale of antimicrobials in the private sector in India. Methods The dataset was obtained from the Indian pharmaceutical sales database, PharmaTrac. The outcome measure was the sales volume of antimicrobials in standard units (SUs). A quasi-experimental research design—interrupted time series analysis—was used to detect the impact of the intervention. Results We observed a substantial rise in antimicrobial consumption during 2008–18 in the private sector in India, both for antimicrobials regulated under Schedule H1 as well as outside the regulation. Key results suggested that post-intervention there was an immediate reduction (level change) in use of Schedule H1 antimicrobials by 10% (P = 0.007), followed by a sustained decline (trend change) in utilization by 9% (P > 0.000) compared with the pre-intervention trend. Segregated analysis on different antimicrobial classes suggests a sharp drop (level changes) and sustained decline (trend changes) in utilization post-intervention compared with the pre-intervention trend. Our findings remained robust on carrying out sensitivity analysis with the oral anti-diabetics market as a control. Post-intervention, the average monthly difference between antimicrobials under Schedule H1 and the control group witnessed an immediate increase of 16.3% (P = 0.10) followed by a sustained reduction of 0.5% (P = 0.13) compared with the pre-intervention scenario. Conclusions Though the regulation had a positive impact in terms of reducing sales of antimicrobials notified under the regulation, optimizing the effectiveness of such stand-alone policies will be limited unless accompanied by a broader set of interventions.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1093/jacamr/dlaa076

Cites

16 of 16 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • 85-90% of all drug prescriptions in India happen in the private sector.

    “previous studies18,20 and national health accounts estimates for India21 have shown that 85-90% of all drug prescriptions happen in the private sector”

    From Consumption of systemic antibiotics in India in 2019 (2022) · cites this paper as [18]

    The Materials and methods > Data and Discussion passages state that about 85%–90% of medicine prescriptions in India occur in the private sector *in value terms*. The citing sentence omits that qualification, so the source does not establish that 85%–90% of prescriptions by number occur there. Page numbers are not provided in our copy's excerpts. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

  • The data did not include drugs dispensed through public facilities, though this is less than 15-20% of all drug sales in India.

    “However, these data did not include the drugs dispensed through public facilities, though this is less than 15–20% of all drug sales in the country as per studies and national health accounts estimates.18,20,21”

    From Consumption of systemic antibiotics in India in 2019 (2022) · cites this paper as [18]

    The Materials and methods > Data passage says the dataset excludes medicines dispensed in government facilities. It also says the government-facility remainder is about 10%–15%, but measures this as a share of medicine prescriptions by value, not of all drug sales without qualification; the Discussion repeats that distinction. (LLM, conf=0.84)

    Experimental — accuracy not yet measured

  • The private sector contributes 85-90% of total antibiotic consumption in India.

    “We examined the private sector antibiotic use, which contributes to 85–90% of the total consumption in India.”

    From Consumption of systemic antibiotics in India in 2019 (2022) · cites this paper as [18]

    The Materials and methods > Data and Discussion passages say that, in value terms, 85%–90% of all medicine prescriptions in India occur in the private sector. They do not establish that the private sector accounts for 85%–90% of antibiotic consumption, which is a different measure and narrower category. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

  • The study used PharmaTrac, a national-level private-sector drug sales audit dataset created by AIOCD Ltd., used by government agencies for policy decisions, including price regulation, and by researchers.

    “We used PharmaTrac, a national-level private-sector drug sales audit dataset created by the All-Indian Origin Chemists and Distributors Ltd. (AIOCD Ltd.), used by government agencies for policy decisions, including price regulation, and by researchers.13,14,17, 18, 19”

    From Consumption of systemic antibiotics in India in 2019 (2022) · cites this paper as [18]

  • The data collected were extrapolated to represent the sales of medicines in the entire private retail sector in India.

    “The data collected were then extrapolated to represent the sales of medicines in the entire private retail sector,18 including the private pharmacy sales of antibiotics against prescriptions from public sector providers.”

    From Consumption of systemic antibiotics in India in 2019 (2022) · cites this paper as [18]

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

Research works printed but not linked: 1

  1. [2]The Review on Antimicrobial Resistance. 2016. Tackling Drug-Resistant Infections Globally: Final Report and Recommendations. https://amr-review.org/sites/default/files/160518_Final%20paper_with%20cover.pdf.

Cited by

Sorted by citations

Related

Authors
Farooqui, H. H., Selvaraj, S., Mehta, A., & Mathur, M. R.
Affiliations
  • Public Health Foundation of India (IN)
  • University of Liverpool (GB)
Corresponding author
Mathur, Manu Raj
ORCID
Venue
JAC-Antimicrobial Resistance
Publisher
Oxford University Press (OUP)
Published
2020-09-01
Volume
2
Issue
3
Pages
dlaa076-dlaa076
ISSN
2632-1823 (ISSN-L)
DOI
10.1093/jacamr/dlaa076
PMC
PMC8210317
OpenAlex
W3090935271
Cited by
16
References
16
Citations by year
2026: 1 · 2025: 2 · 2023: 2 · 2022: 8 · 2021: 3
FWCI
1.93
Type
journal article
Language
en
Open access
Licence
Locations
  • JAC-Antimicrobial Resistance (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Queen Mary Research Online (Queen Mary University of London) (submittedVersion, cc-by)
Topics
  • Life Sciences › Immunology and Microbiology › Applied Microbiology and Biotechnology › Antibiotic Use and Resistance
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
Keywords
prescription-only drugs, antimicrobial resistance, antimicrobial use, Drugs and Cosmetics Act 1940, drug policy evaluation, India

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review